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Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial

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ClinicalTrials.gov Identifier: NCT04091698
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Mostafa Abdelsamie Bakry Nafie, Cairo University

Brief Summary:
The aim of the present investigation is to assess the clinical therapeutic effect of topical use of Coenzyme Q10 versus topical corticosteroid in management of symptomatic oral lichen planus and determine whether the effect, if any, was due to its antioxidant activity.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Co-Enzyme Q10 mucoadhesive tablets Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two parallel group one take Q10 mucoadhesive tablets and other take topical corticosteroid for 3 months follow up measuring pain ,clinical size of lesion and salivary level of Malondialdehyde as oxidative biomarker
Masking: Single (Outcomes Assessor)
Masking Description: Double-blinded trial, outcome assessors and statistician
Primary Purpose: Treatment
Official Title: 11 El-Saraya St. - Manial - Cairo
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: topical Q10 mucoadhesive tablets
will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.
Drug: Co-Enzyme Q10 mucoadhesive tablets
will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.
Other Name: Q10 mucoadhesive tablets -ubiquinol

Placebo Comparator: topical corticosteroid
will receive topical corticosteroid (kenacort A Orabase: triamcinolone acetonide 0.1%5gram adhesive paste - dermapharm), 4 times daily for 3months.
Drug: Co-Enzyme Q10 mucoadhesive tablets
will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.
Other Name: Q10 mucoadhesive tablets -ubiquinol




Primary Outcome Measures :
  1. pain score [ Time Frame: 3months ]
    visual analogue scale scoring system

  2. clinical size of lesion [ Time Frame: 3months ]
    Thongprasom score system


Secondary Outcome Measures :
  1. Salivary level of Malondialdehyde [ Time Frame: 3months ]
    detect by ELISA



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients free from any systemic disease according to the detailed questionnaire of the modified Cornell Medical Index 34.
  2. Patients not receiving any medication either topical or systemic that could cause lichenoid reaction during the 3 months before the study.
  3. Patients diagnosed by a dermatologist and oral medicine specialist as suffering from OLP.
  4. Patients clinically and histopathologically diagnosed as suffering from OLP according to World Health Organization's (WHO's) clinic-pathological diagnostic criteria for LP35.
  5. Patients who agree for the biopsy in undiagnosed cases.
  6. Patients who are willing to participate in this study (will give informed consent) and have the ability to complete the study.

    • Exclusion criteria:

(1) Patients taking systemic drugs such as systemic steroid, other immunosuppressive therapy for at least 8 weeks prior to the study.

(2) Patients treated with any oral topical medications for at least four weeks prior to the study.

(3) Patients with suspected restoration-related reaction. (4) Pregnant and lactating mothers.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091698


Contacts
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Contact: mostafa abdelsamie, demonstrator 01004165905 mostafa.abdelsamie@dentistry.cu.edu.eg
Contact: fatheya zahran, professor fatheya.zahran@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Mostafa Abdelsamie Bakry Nafie, demonstrator, Cairo University
ClinicalTrials.gov Identifier: NCT04091698     History of Changes
Other Study ID Numbers: Q10 in oral lichen planus
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mostafa Abdelsamie Bakry Nafie, Cairo University:
co enzymeQ10 - Antioxidant- Corticosteroids
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Coenzyme Q10
Ubiquinone
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs